Device product
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Z-0558-2022
Product summary
- Event
- Event 89455
- Status
- Terminated
- Classification
- Class II
- Quantity
- 162,000 ea
- Official record key
device-enforcement:Z-0558-2022
Official wording
Reason: The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
Code information: All lots
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.